A Randomized, Controlled, Multi-center Study on the Effectiveness of Traumeel S (Both Ointment and Gel) in Terms of Pain and Function Compared With a Topical NSAID in Athletes With Acute Ankle Sprain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
研究概览
简要总结
The objective of this study is to determine the efficacy of Traumeel S (both ointment and gel) compared to another antiinflammatory drug called Diclofenac in patients with a sprained ankle.
详细描述
Study objective is the confirmatory proof of efficacy for Traumeel® S topical treatment, both ointment and gel, as compared to diclofenac topical treatment for patients with ankle sprain. In addition tolerability/safety of both drug preparations is to be compared, so that the benefit-risk relation can be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Similar injury affecting the same joint within the past 6 months
- •bilateral ankle injury
- •bed rest, hospitalization, surgery use of a non-removable rigid cast
- •Clinically important abnormality for screening laboratory tests
- •Debilitating acute or chronic illness
- •Use of corticosteroids in the previous 8 weeks, any analgesics in the previous 6 hours, or 24 hours in case of long-acting NSAID, COX-2 specific inhibitors, or tramadol
- •History of sensitivity to any component of the study drugs
- •Unwilling or unable to comply with all the requirements of the protocol
- •Participation in other studies within 4 weeks prior to study entry and or during the study participation
- •Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study result
研究组 & 干预措施
Traumeel S ointment
Traumeel S ointment 2 g, 3 times daily topical during 14 days
干预措施: Traumeel S ointment (Drug)
Traumeel S gel
Traumeel S gel 2 g, 3 times daily topical during 14 days
干预措施: Traumeel S gel (Drug)
Diclofenac gel
Diclofenac gel 2 g, 3 times daily topical during 14 days
干预措施: Diclofenac gel (Drug)
结局指标
主要结局
Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7
时间窗: From baseline (day 1) visit to day 7
Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis. The highest is the change in negative, the better are the results in absolute values.
Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7
时间窗: Day 1 to day 7
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to 'unable to do' (score 0). Responses marked as ´not applicable´were not counted. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7
时间窗: From baseline (day 1) visit to day 7
Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis. The highest is the change in negative, the better are the results in percentages.
次要结局
- FAAM ADL Subscale(Day 1 to 4, 14, 42)
- FAAM Sports Subscale(Day 1 to 4, 7, 14, 42)
- Swelling ('Figure-of-eight')(Day 1 to 4,7,14)
- Physician's Assessment of Normal Function/Activity (5-point-scale)(Day 1 to 4, 7, 14, 42)
- Time to Normal Function (Training/Sports)(Day 1 to 4, 7, 14, 42)
- Global Judgment of Efficacy(Day 14)